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Regulatory Affairs Manager – Medical Devices (m/f) Regulatory Affairs Biopharmaceuticals, Sandoz GmbH, Kundl Areas of Responsibility
Preparation, coordination and compilation of regulatory documentation and dossiers for Medical Device registrations worldwide
Liaise with notified bodies and regulatory authorities during medical device registration procedures and during lifecycle
Participation in audits by a notified body or agencies
Maintenance of medical device registrations in accordance to new regulatory and technical requirements and as required from technical and labeling changes
Regulatory support to the technical departments as well as to QA functions and manufacturing departments during development and lifecycle of medical devices
Support the generation and maintenance of design history files
Close monitoring of regulatory requirements issued by the authorities and evaluation of their relevance for the registration status of our products
Qualifications
Education: PhD, preferably in biotechnology, biology, biochemistry
Languages: English (fluent) / German (basics) beneficial
Experience: min. 3-5 years’ experience in regulatory affairs, ideally with background on medical devices used for the administration of biotech products
Personal skills: Team player with outstanding interpersonal and communication skills and integrative thinking
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labor agreement, we advise you that the minimum gross annual salary for this role is EUR 47,102-. Please apply online, under www.sandoz.com / career / career opportunities / Job ID 152484BR
Sandoz is an equal opportunity employer

While applying for the job please refer on jobvector and use the following reference number: 152484BR